Granules India Limited announces approval of Potassium Chloride Oral Solution USP

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India Limited, for Potassium Chloride Oral Solution USP, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%). It is bioequivalent to the reference listed drug product (RLD), Potassium Chloride Oral Solution, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%), of Genus Lifesciences, Inc. The product would be available in bottle of 473 ml and is expected to be launched shortly.

"We are pleased to announce approval of first oral liquid product from our growing product portfolio in the US market. This is third approval in the Potassium Chloride product basket reiterating our focussed portfolio strategy." said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval.

Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.

Granules now has a total of 36 ANDA approvals from US FDA (35 Final approvals and 1 tentative approvals).

Potassium Chloride Oral solution products had U.S. sales of approximately $75 million for the most recent twelve months ending in November 2020 according to IQVIA Health.

Shares of GRANULES INDIA LTD. was last trading in BSE at Rs.337.15 as compared to the previous close of Rs. 353.55. The total number of shares traded during the day was 81762 in over 3497 trades.

The stock hit an intraday high of Rs. 354.8 and intraday low of 335.05. The net turnover during the day was Rs. 27833339.

Source : Equity Bulls

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